Echosens
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories1
Latest FDA decision2023-03-02
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K223902 | FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) | IYO | 2023-03-02 | View |
| 510(k) | K212035 | FibroScan 230 | IYO | 2021-07-30 | View |
| 510(k) | K203273 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) | IYO | 2021-03-25 | View |
| 510(k) | K200655 | FibroScan® 630 | IYO | 2020-07-16 | View |
| 510(k) | K181547 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | IYO | 2018-07-09 | View |
| 510(k) | K173034 | FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) | IYO | 2017-11-14 | View |
| 510(k) | K172142 | FibroScan 430 Mini+ | IYO | 2017-09-13 | View |
| 510(k) | K160524 | FibroScan 530 Compact | IYO | 2016-03-18 | View |
No matching devices.